Effects of Electroacupuncture to Relieve Itching Degree in Patients With Chronic Atopic Eczema

Shanghai Yueyang Integrated Medicine Hospital

Status: Not yet enrolling

Conditions: Chronic Lichenified Atopic Dermatitis

Treatments: Device: electroacupunture; Device: sham acupuncture; Device: sham electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05529836

22Y11922200

Details and patient eligibility

About

Eczema is a common allergic skin disease, accounting for about 15 to 30% of dermatological outpatients. Pruritus as one of the most painful symptoms is often underestimated in terms of the problems that it can cause, which creates the vicious loop of itching, scratching, and lichenification. Therefore, further research into practical and safe treatments that eliminate itchy symptoms and enhance skin protection is the key to overcoming chronic atopic eczema. Acupuncture has been utilized clinically in China for thousands of years due to its benefits of being practical, affordable, and simple to execute. With modern science and technology advancements, electroacupuncture (AE) has become widely used in China's public hospitals to treat chronic atopic eczema. This trial aims to objectively evaluate the clinical efficacy and safety of the electroacupuncture antipruritic technique in chronic atopic eczema pruritus and to obtain its high-level clinical evidence for the popularization and application of electroacupuncture clinical treatment of chronic atopic eczema.

Full description

As a common allergic skin disease, the incidence of eczema is increasing year by year, accounting for about 15 ~ 30% of the dermatological outpatients. Pruritus is one of the most painful symptoms of eczema. Patients often form a vicious circle of "pruritus -- scratching -- mossy transformation" because they can't stand it. Research on safe and effective anti-pruritus program has become the key to treatment. Inheriting the experience of Xia's surgery in Shanghai, the team proposed the core pathogenesis of "blood heat and dampness heat", formulated the treatment principle of "cooling blood dehumidification", selected acupoints Quchi (LI4), Hegu (LI11), Xuehai (SP10) and Sanyi jiao (SP6), and used the original acupuncture anti-pruritus technique (modified by acupuncture anesthesia technique) to treat chronic eczema with clinical advantages. Small sample Pilot study showed that acupuncture antipruritic technique significantly reduced the visual analogue scale (VAS) score of patients with chronic eczema, which was significantly better than sham EA group and non-EA group. This project adopts the multicenter, randomized, including false contrast design, objective, normative evaluation of acupuncture for chronic eczema itching itching and technology to improve situation, clinical efficacy and safety, obtain exact clinical evidence, further to form suitable for standardization, popularization and application in wide range of chronic eczema itching technology clinical acupuncture specification.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meeting the TCM syndrome differentiation criteria and Western medicine diagnostic criteria for chronic eczema;
2. between the ages of 18 and 65;
3. BSA score < 10%;
4. Agree to participate in clinical trial observation and cooperate with regular visitors;
5. Sign and date the informed consent;

Exclusion criteria

1. Patients who have been systematically treated with hormones or immunosuppressants within two weeks;
2. Recipients who are not durable to acupuncture;
3. Patients with severe secondary infection symptoms, including local skin infection and systemic infection of other organs;
4. Women who are pregnant, breastfeeding or planning to become pregnant during the trial;
5. Diabetes mellitus or patients with severe heart, liver and kidney disease;
6. Those who have received other research drugs or participated in other clinical trials within 3 months;
7. Unable to cooperate with the research for any reason, such as: language comprehension, unable to go to the research center for treatment, etc.;
8. Patients with generalized eczema, skin lesions all over the body and inconvenient for acupuncture;
9. Acute onset of chronic eczema.
10. BSA score ≥10%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 3 patient groups, including a placebo group

electroacupuncture(EA) group

Experimental group

Description:

The participants in EA group will receive acupuncture with PSD at bilateral Hegu (LI4), bilateral Quchi (LU5), bilateral Xuehai (SP10) and bilateral San Yinjiao (SP6). After skin disinfection, followed at an angle of 90°, acupuncture needles were inserted approximately 50 to 60 mm into the skin. When achieving qi, connect the four pairs of electrodes, two each on bilateral Quchi (LI4) and Hegu (LI11), two each on bilateral Xuehai (SP10) and San Yinjiao (SP6), and they are all ipsilateral to one another. The duration of the electroacupuncture stimulation is 30 minutes, and the current intensity ranges from 1 to 5 mA with a continuous wave of 20 Hz. For two weeks straight, the participants will have three therapy sessions each week (preferably every other day), for a total of six sessions.

Treatment:

Device: electroacupunture

sham electroacupuncture(SEA) group

Sham Comparator group

Description:

Participants in the SEA group will receive sham electroacupuncture with PSD, but not energizing the electropuncture device. Procedures, electrode placements, and other treatment settings are the same as in the EA group but with no electricity output only.

Treatment:

Device: sham electroacupuncture

sham acupuncture(SAC) group

Placebo Comparator group

Description:

Participants in the SAC group will receive sham acupuncture with PSD and PSN on sham acupoints (the non-meridian and non-acupuncture points). Procedures, electrode placements, and other treatment settings are the same as in the EA group but with no skin penetration, electricity output, or needle manipulation for achieving qi.

Treatment:

Device: sham acupuncture